GUAIFENESIN SOLUTION [HI-TECH PHARMACAL CO., INC.]

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GUAIFENESIN SOLUTION [HI-TECH PHARMACAL CO., INC.]
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NDC 50383-063-05, 50383-063-06, 50383-063-07, 50383-063-10, 50383-063-11, 50383-063-12, 50383-063-15, 50383-063-17, 50383-063-18
Set ID 5cb704a7-301c-494e-948f-872ee0d5a289
Category HUMAN OTC DRUG LABEL
Packager Hi-Tech Pharmacal Co., Inc.
Generic Name
Product Class
Product Number
Application Number PART341
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  • Active ingredient

    Each 5 mL (1 teaspoonful) contains:

    Guaifenesin ................................................ 100 mg

  • Inactive ingredients

    Acesulfame K, artificial cherry & vanilla flavor, aspartame, hypromellose, menthol, methylparaben, potassium sorbate, purified water. Citric acid may be used to adjust pH.

  • Purpose

    Expectorant

  • Uses

    Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.

  • Warnings

    Ask a doctor before use if you have

    •
    cough that occurs with too much phlegm (mucus)
    •
    cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

    Stop use and ask a doctor if

    •
    cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
    •
    you are hypersensitive to any of the ingredients

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away.

    Professional Note: Guaifenesin has been shown to produce a color interference with certain clinical laboratory determinations of 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA).

  • Directions

    Follow dosage below or use as directed by a physician.

    •
    do not take more than 6 doses in any 24-hour period

    age

    dose

    adults and children 12 years and over

    10 to 20 mL (2 to 4 teaspoonfuls) every 4 hours

    children 6 years to under 12 years

    5 to 10 mL (1 to 2 teaspoonfuls) every 4 hours

    children 2 to under 6 years of age

    2.5 to 5 mL (1/2 to 1 teaspoonful) every 4 hours

    children under 2 years of age

    ask a doctor

    How Supplied:

    Guaifenesin Oral Solution is a clear viscous liquid with a slight cherry odor supplied in the following oral dosage forms: 5 mL unit dose, 10 mL unit dose, 15 mL unit dose in trays of 10 and 4 fl. oz. (118 mL) bottle

    Phenylketonurics: contains phenylalanine 8.4 mg per teaspoonful (5 mL)

  • STORAGE

    Keep tightly closed. Store at controlled room temperature, 20°-25°C (68°-77°F). [See USP] Protect from light.

  • Questions or comments?

    Call 1-800-262-9010.


    Hi-Tech Pharmacal Co., Inc.

    Amityville, NY 11701

    Rev.063:01 4/13

    MG #29850

  • Package/Label Principal Display Panel

    Lid - 15 mL

    Delivers 15 mL

    NDC 50383-063-15

    GUAIFENESIN ORAL SOLUTION

    300 mg/15 mL

    Sugar Free/Alcohol Free

    EXPECTORANT

    SEE INSERT

    FOR INSTITUTIONAL USE ONLY

    Hi-Tech Pharmacal Co., Inc.

    Amityville, NY 11701

    Rev. 063:01 4/13

  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN 
    guaifenesin solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50383-063
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    ASPARTAME (UNII: Z0H242BBR1)  
    HYPROMELLOSE 2910 (4000 MPA.S) (UNII: RN3152OP35)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    WATER (UNII: 059QF0KO0R)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRY (artificial cherry flavor) , VANILLA (artificial vanilla flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50383-063-064 in 1 CASE03/07/2012
    1NDC:50383-063-0510 in 1 TRAY
    15 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    2NDC:50383-063-0710 in 1 CASE03/07/2012
    210 in 1 TRAY
    25 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    3NDC:50383-063-114 in 1 CASE03/07/2012
    3NDC:50383-063-1010 in 1 TRAY
    310 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    4NDC:50383-063-1210 in 1 CASE03/07/2012
    410 in 1 TRAY
    410 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    5NDC:50383-063-174 in 1 CASE03/07/2012
    5NDC:50383-063-1510 in 1 TRAY
    515 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    6NDC:50383-063-1810 in 1 CASE03/07/2012
    610 in 1 TRAY
    615 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/07/2012
    Labeler - Hi-Tech Pharmacal Co., Inc. (117696873)
    Registrant - Akorn Operating Compnay LLC (117693100)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hi-Tech Pharmacal Co., Inc.117696873MANUFACTURE(50383-063) , ANALYSIS(50383-063) , PACK(50383-063)
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